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An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions

NCT06671405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-04-27

No results posted yet for this study

Summary

An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of AZD0780 when administered alone and in combination with itraconazole and carbamazepine, and to assess the pharmacokinetics of midazolam and ethinyl estradiol/levonorgestrel (EE and LNG) when administered alone and in combination with AZD0780.

Conditions

  • Dyslipidaemia

Interventions

DRUG

AZD0780

Dose 1 and Dose 2

DRUG

Itraconazole

* Period 2 (itraconazole administration only). * Period 3 (AZD0780 + itraconazole administration).

DRUG

Carbamazepine

* Period 2 (carbamazepine administration only). * Period 3 (AZD0780 + carbamazepine administration only).

DRUG

Midazolam

* Period 1 (midazolam administration only). * Period 3 (AZD0780 + midazolam administration).

DRUG

Ethinyl estradiol/levonorgestrel

* Period 1 (EE and LNG administration only). * Period 3 (AZD0780 + EE and LNG administration).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2025-02-17
Completion
2025-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671405 on ClinicalTrials.gov